eCTD - Electronic Common Technical Document

Virtify eCTD Electronic Submissions Management solution is a single solution to author, compile, review, QC, publish, and transmit Electronic Common Technical Documents (eCTD). It eliminates the need to deploy and manage multiple products for eCTD submissions.

Virtify eCTD is built on Virtify’s well known XML-based platform, which is designed to conform with HL7 and ICH standards. It is a complete web based solution that requires no client side downloads eliminating software deployment complexities involved with upgrades, patches and schema changes.

The web based architecture provides a multi-user environment for users to work on different parts of a submission concurrently. The solution provides the status of documents at different phases of the submission with appropriate icons, alerts and notifications.

• Ajax enabled
• Complete Web Based Solution in a collaborative multi-user environment
• Loading Documents from the Desktop, Network Shares and Document Management Systems
• Seamless Integration with SPL and PIM Products including Virtify SPL
• Intelligent Validation Engine
• Verification of broken links
• FDA Electronic Gateway Compliant Submissions
• Integration with commercially available document management systems
• Advanced Search and Reporting Capabilities
• Validated Solution
• Loading Documents from the Desktop, Network Shares and Document Management Systems
• Create and Manage Library Content

Virtify eCTD significantly differs from conventional client-server or hybrid web-based client-server products by providing a complete web-based solution with a central repository. This helps support a multi-user collaborative environment where users can work on the same submission and get access to information in real time about the status of all submissions from one common interface. The web– based architecture provides significant cost savings by eliminating the need to configure, install and deploy upgrades, and add changes to schema.

Virtify eCTD provides the capability to upload files from a user’s desktop, network file system or commonly used document management systems through a single interface. This provides the flexibility to load documents seamlessly from different locations without having to navigate to different applications.

Virtify eCTD has an intelligent validation engine built into it that proactively monitors user actions and prevents any operations that may lead to potential errors downstream. This greatly reduces the time that organizations typically spend during the validation and QC processes at the end of the submissions process.

Virtify eCTD provides the capability to store a document, set of documents, whole or part submissions into a reusable library enabling content to be shared across regional submissions. This ensures the use of consistent content across submissions and easily identifies the impact of a change to a shared library item. For example - a set of files common to a submission in Europe, Canada and the US can be stored and referenced from the library. If any of these files changes, the system automatically alerts the user about all submissions that need to be updated.